510(k) · Cleared
ClearedAcuityDRe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radmedix, LLC · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Apr 30, 2021 as substantially equivalent to K201058 (Radmedix, LLC, 2020) after a 32-day review. Its family tree reaches back 13 generations to 1990. 3 later devices descend from it.
- Decided
- Apr 30, 2021
- Review
- 32 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K896095 (1990). 25 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations between
- 3 generations backK191451 CMDR 2CW (Multiple models)Minxray, Inc. · 2019
- 2 generations backK200726 AcuityPDRRadmedix, LLC · 2020
- 1 generation backK201058 Accuvue+Radmedix, LLC · 2020
- This deviceK210919 AcuityDReRadmedix, LLC · 2021
- Descendant · cites it directly · 1 of its ownK214030 Universal DR 1748Konica Minolta Healthcare Americas, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK252996 Universal 1417PIKonica Minolta Healthcare Americas, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK231709 AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC · 2023
Show all 13 generations
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 12 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 11 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 10 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 9 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 8 generations backK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- 7 generations backK091364 Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4Oehm Und Rehbein GmbH · 2009
- 6 generations backK100449 Minxray Model CMDR-2SMinxray, Inc. · 2010
- 5 generations backK141885 CMDR-2ST & CMDR-2SLWT Digital Portable X-RayMinxray, Inc. · 2014
- 4 generations backK171353 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc. · 2017
- 3 generations backK191451 CMDR 2CW (Multiple models)Minxray, Inc. · 2019
- 2 generations backK200726 AcuityPDRRadmedix, LLC · 2020
- 1 generation backK201058 Accuvue+Radmedix, LLC · 2020
- This deviceK210919 AcuityDReRadmedix, LLC · 2021
Most influential descendants
Showing 3 of 3 · See all- K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc. · 2022 · cites it directly1descendant
- K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc. · 2026 · 2 generations on0descendants
- K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −12 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −11 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −10 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −9 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −8 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| −7 | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | Oehm Und Rehbein GmbH | 2009 | — |
| −6 | K100449 | Minxray Model CMDR-2S | Minxray, Inc. | 2010 | — |
| −5 | K141885 | CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray | Minxray, Inc. | 2014 | — |
| −4 | K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | Minxray, Inc. | 2017 | — |
| −3 | K191451 | CMDR 2CW (Multiple models) | Minxray, Inc. | 2019 | — |
| −2 | K200726 | AcuityPDR | Radmedix, LLC | 2020 | — |
| −1 | K201058 | Accuvue+ | Radmedix, LLC | 2020 | — |
| 0 (this device) | K210919 | AcuityDRe | Radmedix, LLC | 2021 | — |
| +1 | K214030 | Universal DR 1748 | Konica Minolta Healthcare Americas, Inc. | 2022 | — |
| +2 | K252996 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | 2026 | — |
| +1 | K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Radmedix, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K201058 | Accuvue+Summary page 4…II Product Code: MQB, LLZ Substantially equivalent device: Trade Name: Accuvue+ Manufacturer: RadmediX 510(k) #: K201058 Classification Name: Stationary x-ray system Classification Panel: Radiology Classification R… | 2020 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K214030 (Konica Minolta Healthcare Americas, Inc., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210919 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210919: AcuityDRe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210919
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026